Comparing BCMA CAR-T therapy to stem cell transplant for multiple myeloma
A Prospective, Non-inferiority Study Comparing VRD±D Followed by BCMA CAR-T Cell Therapy Versus VRD±D Followed by Autologous Hematopoietic Stem Cell Transplantation in Transplant-eligible Patients With Newly-diagnosed Multiple Myeloma
This study is testing if a new CAR-T therapy for multiple myeloma works just as well as a stem cell transplant for patients who are eligible for both treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06793449 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, non-inferiority trial that evaluates the effectiveness of BCMA CAR-T cell therapy compared to autologous hematopoietic stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. Participants will receive either treatment following a regimen of VRD±D. The goal is to determine if BCMA CAR-T therapy is as effective as ASCT for transplant-eligible patients. The study will involve measuring disease response and patient outcomes over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with measurable multiple myeloma and confirmed BCMA expression on their cancer cells.
Not a fit: Patients with primary plasma cell leukemia, concurrent amyloidosis, CNS involvement, or prior BCMA-targeted therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that may improve outcomes for patients with multiple myeloma.
How similar studies have performed: Other studies have shown promise with CAR-T therapies in hematological malignancies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be informed and voluntarily sign the Informed Consent Form (ICF). 2. Age between 18 and 70 years (inclusive). 3. Have measurable disease meeting at least one of the following criteria: Serum M-protein ≥1 g/dL (\>10 g/L) as detected by serum protein electrophoresis (SPEP), or quantifiable IgA or IgD levels for IgA or IgD-type myeloma; Urine M-protein ≥200 mg/24 hours; In cases where serum and urine M-protein do not meet the above thresholds, an abnormal free light chain (FLC) ratio (normal range: 0.26 to 1.65) and involved serum FLC ≥100 mg/L. 4. Confirmed expression of the BCMA target antigen on MM cells by flow cytometry or bone marrow immunohistochemistry. 5. Assessed by the investigator as transplant-eligible. Exclusion Criteria: 1. Primary plasma cell leukemia. 2. Concurrent amyloidosis. 3. Involvement of the central nervous system (CNS). 4. Previous treatment with BCMA-targeted therapy or CAR-T cell therapy.
Where this trial is running
Tianjin
- Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Gang An, PhD&MD
- Email: angang@ihcams.ac.cn
- Phone: 86-022-23909171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.